House debates

Thursday, 16 February 2006

Therapeutic Goods Amendment (Repeal of Ministerial Responsibility for Approval of Ru486) Bill 2005

Second Reading

10:25 am

Photo of Margaret MayMargaret May (McPherson, Liberal Party) Share this | Hansard source

It is not often that members have the right to cast a free vote in this place and be bound not by party lines but by our individual consciences. It is a rare occurrence and the responsibility of this conscience vote is indeed overwhelming, particularly in view of the huge volume of information that has been provided to all members on this important private member’s bill.

Before making my decision to support the Therapeutic Goods Amendment (Repeal of Ministerial responsibility for approval of RU486) Bill 2005, I weighed up and considered very carefully the facts and information provided in relation to the bill. I have listened to both sides of the debate in both chambers and read and studied the views of the community. I would like to put on record my sincere thanks to all those people who have contacted my office by phone, by email and by letter. The input from many individuals, people I highly respect, has also been welcome.

As members of parliament we are elected by our constituents to make the tough decisions, and there are times when not all will agree with the decisions we make. I know my decision to support the bill will upset some in my constituency, but I have not taken my position lightly or without a lot of thought and consideration. In the brief time available to me today I would like to explain why I have made this decision.

This debate is not an abortion debate. It is not a debate about the morality of abortion or the principles and values of members elected to this House; this is a debate about the process of approval—a debate about separating politics from medical decision making. The abortion debate happened many years ago. Abortion is legal in this country. Men and women democratically elected to our state and territory parliaments made laws with regard to abortion and the criteria that must be met to terminate a pregnancy. These laws have been in existence across this country since the late 1970s.

That is not to say that abortion is not a very difficult and sensitive issue. We have certainly witnessed that by the emotions evoked in the community over the last few weeks. There is not a person in this place, nor I would suggest in this country, who supports abortion. All of us would prefer that no woman were ever confronted with the trauma of an unwanted or non-viable pregnancy, but it is not my position to pass judgment on a woman’s decision to terminate a pregnancy. That decision is between a woman, her doctor, her partner and her family.

As an elected member of this House it is my responsibility to ensure that a woman is able to undertake a termination in accordance with state and territory laws, knowing that this country provides the safest and most effective means available under medical supervision to undergo that termination. Of course, we would all like to see fewer abortions—that goes without saying—but that is a debate for another time. That is not what this private member’s bill is about. As I said before, this bill is about the process for approval of a drug known as RU486; it is not a debate about my position on abortion nor indeed the parliament’s position on abortion.

That brings me to the bill before the House today. I think it is important that the community understands what is being debated and why we are having this debate. This debate is about who is best equipped to identify, assess and evaluate the risks of RU486, a drug which belongs to a special category of drugs under the Therapeutic Goods Act 1989 known as restricted goods. It is my view that the Therapeutic Goods Administration is the body to undertake that process. I do not have the expertise, nor, could I respectfully suggest, does the minister for health, to undertake an evidence based risk evaluation of RU486.

In my view, members of this House and of the Australian community who are concerned about the safety and efficacy of this drug should welcome a scientific, evidence based evaluation by the TGA. That evaluation by eminent specialists, all appointed by the Minister for Health and Ageing, will ensure that women in this country can make an informed, safe and educated choice about whether or not they undertake a medical termination or a surgical termination. Women should be provided with all the options available to them so they can make that informed choice.

It is important that the community understands that access to a medical termination using RU486 is not about over-the-counter, do-it-yourself termination. Access to RU486 is not about making abortion easier for women. To comply with state and territory laws, terminations—whether procured medically or surgically—require medical oversight and approval. If a state requires that a woman satisfy physical and mental health tests before qualifying for a surgical abortion, she will be required to satisfy the same tests to have a lawful termination using medical methods.

So, who or what is the Therapeutic Goods Administration? What is the make-up of this body, and what is its role? The TGA is a unit of the Australian government Department of Health and Ageing. Its role is to carry out a range of assessment and monitoring activities to ensure that therapeutic goods available in Australia are of an acceptable standard, with the aim of ensuring that the Australian community has access, within a reasonable time, to therapeutic advances. The current government and former governments have trusted this body to assess the safety and effectiveness of tens of thousands of medicines, many of them dangerous, and it is my view that that trust should continue in the future. I repeat: the TGA is an arm of the Australian government Department of Health and Ageing.

A committee of the TGA is the Australian Drug Evaluation Committee, or ADEC, a committee that was formed in 1963 and given the role of providing independent scientific advice on new drugs, within the policy framework of the time, to the federal government. The Minister for Health and Ageing appoints the members of the Australian Drug Evaluation Committee. The appointments to the committee include six or seven core members and 10 to 20 associate core members. The make-up of this committee—the eminent men and women appointed by the minister—is impressive. They are leading specialists in a variety of medical fields. In my view, they are highly capable of assessing and evaluating the safety and the efficacy of RU486. These eminent people are not faceless, unaccountable, undemocratic bureaucrats; they are appointed by the minister and accountable to the minister.

Based on this information, it is my belief that the TGA, with such eminent men and women, has the ability to assess the quality, safety and efficacy of this drug. With no disrespect to my colleagues, I do not believe we are qualified, nor do we in this House have the expertise or ability to undertake the assessment process of RU486. This is a job for the experts, and those experts are in place, appointed by the minister, to carry out that assessment process.

I am more than satisfied, and I would like to assure my community, that this evaluation committee can and should undertake the assessment process and report back to the Minister for Health and Ageing on the safety and efficacy of the drug so that Australian women, in consultation with their medical practitioners, can make an informed decision about a medical termination if and when they are faced with that situation.

Over the last couple of days there have been many speakers on this bill. There have been emotive arguments and many different points of view, and the spirit in which the debate has been undertaken is a credit to all in this House.

On a final note, I would like to comment on the amendment that has been put forward to the House by the honourable member for Lindsay and on the second amendment that has been flagged by the member for Bowman. He has indicated that he will table that amendment during the consideration in detail stage. I have taken the time to read both those amendments, and I reject them. I do not support either of the proposed amendments. I will be supporting the bill as it stands.

A free vote is not easy. It is up to the individual to weigh up the arguments, the issues and the public input, to do their own research and evaluation of the information that is available and to satisfy themselves on the integrity of the bill before the House. I am satisfied that the Therapeutic Goods Administration is the appropriate and best equipped body to undertake the expert assessment, to weigh up the medical evidence and to deliver a considered judgment about the risk and benefits profile of the drug. I commend the bill to the House.

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